(NaturalNews) For the third time, Merck is seeking FDA approval for over-the-counter sale of its cholesterol-lowering statin medication lovastatin, marketed under the brand name Mevacor.
An FDA advisory panel voted against approving the drug for over-the-counter use on December 14, 2007. The recommendations of FDA advisory panels are not binding, but the agency usually follows them. After similar recommendations in 2000 and 2005, the FDA rejected Merck's applications to sell Mevacor over the counter.
In its December 14 decision,
the FDA panel cited concerns that patients are not able to determine for themselves whether the cholesterol-lowering
medication is right for them, the same concern cited in 2000 and 2005. The
FDA has noted that high
cholesterol is a chronic condition lacking overt symptoms, unlike other
health problems that are currently treated over the counter.
"People can't, on their own, evaluate whether they are at sufficient enough risk that they could benefit from this
drug," said physician Sidney Wolfe, who testified against the drug's approval to the FDA panel. Wolfe is the director of the Public Citizen Health Research Group.
At the FDA's recommendation,
Merck added new warnings to the proposed
labels for over-the-counter
Mevacor since 2005. The labels say that the drug should not be used by men under the age of 45,
women under the age of 55, pregnant or nursing women, or women who might become pregnant while taking the drug. According to Merck, recent studies indicated that the new labels helped consumers make better decisions about whether to take the drug. The FDA advisory panel disagreed.
The FDA is expected to decide on January 26 (2008?) whether to approve Merck's application. According to pharmaceutical
industry consultant Steve Francesco, a decision to approve over-the-counter Mevacor "would be a real turning point" for the industry, paving the way for the approval of other over-the-counter medicines including more statins and drugs for allergy, dermatology and heartburn.
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